MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING

Model Number 442023

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 4 bd bactec¿ plus aerobic/f culture vials (plastic) produced false positive results.Gram stains were performed with 2 vials presenting positive bacilli, but culture growth was not found on any of the vials.Two of the erroneous results were reported to clinicians, but no patients were treated based on them, and there was no report of any other adverse patient impact.The following information was provided by the initial reporter: "customer reporting nonviable contamination leading to false positive report using 442023 - bactec plus aerob/f lot 1230635." "4 vials flagged around 1 hour from entry due to sensor adhesion issues ((b)(4)); vials were stained and cultured; 2 of 4 vials presented with gram positive bacilli on the gram stain; 0 of 4 vials had culture growth.1 of 4 vials sent to phol for 16s pcr." "were any erroneous results reported to the doctors? two erroneous results were reported in the gram stain."gram positive bacilli" (initially reported).This was corrected to "no organisms seen".If yes, were any patients treated based on erroneous results? no patients were treated based on erroneous results.If yes, did the erroneous treatment have any adverse impact to the patient(s)? n/a".

Event Description

It was reported that a bd bactec¿ plus aerobic/f culture vials (plastic) produced false positive results.A gram stain was performed with the vial presenting positive bacilli, but culture growth was not found.There was no report of patient impact the following information was provided by the initial reporter: "customer reporting nonviable contamination leading to false positive report using 442023 - bactec plus aerob/f lot 1230635." "4 vials flagged around 1 hour from entry due to sensor adhesion issues (case 01521797); vials were stained and cultured; 2 of 4 vials presented with gram positive bacilli on the gram stain; 0 of 4 vials had culture growth.1 of 4 vials sent to phol for 16s pcr." "1.Were any erroneous results reported to the doctors? two erroneous results were reported in the gram stain "gram positive bacilli" (initially reported).This was corrected to "no organisms seen".2.If yes, were any patients treated based on erroneous results? no patients were treated based on erroneous results.3.If yes, did the erroneous treatment have any adverse impact to the patient(s)? n/a".

Manufacturer Narrative

The following fields were updated with corrections: b.5.Event description: " it was reported that a bd bactec¿ plus aerobic/f culture vials (plastic) produced false positive results.A gram stain was performed with the vial presenting positive bacilli, but culture growth was not found.There was no report of patient impact the following information was provided by the initial reporter: "customer reporting nonviable contamination leading to false positive report using 442023 - bactec plus aerob/f lot 1230635." "4 vials flagged around 1 hour from entry due to sensor adhesion issues (case(b)(4)); vials were stained and cultured; 2 of 4 vials presented with gram positive bacilli on the gram stain; 0 of 4 vials had culture growth.1 of 4 vials sent to phol for 16s pcr." "1.Were any erroneous results reported to the doctors? two erroneous results were reported in the gram stain "gram positive bacilli" (initially reported).This was corrected to "no organisms seen".2.If yes, were any patients treated based on erroneous results? no patients were treated based on erroneous results.3.If yes, did the erroneous treatment have any adverse impact to the patient(s)? n/a" ".

Event Description

It was reported that 4 bd bactec¿ plus aerobic/f culture vials (plastic) produced false positive results.Gram stains were performed with 2 vials presenting positive bacilli, but culture growth was not found on any of the vials.Two of the erroneous results were reported to clinicians, but no patients were treated based on them, and there was no report of any other adverse patient impact.The following information was provided by the initial reporter: "customer reporting nonviable contamination leading to false positive report using 442023 - bactec plus aerob/f lot 1230635." "4 vials flagged around 1 hour from entry due to sensor adhesion issues (case (b)(4)); vials were stained and cultured; 2 of 4 vials presented with gram positive bacilli on the gram stain; 0 of 4 vials had culture growth.1 of 4 vials sent to phol for 16s pcr." "1.Were any erroneous results reported to the doctors? two erroneous results were reported in the gram stain "gram positive bacilli" (initially reported).This was corrected to "no organisms seen".2.If yes, were any patients treated based on erroneous results? no patients were treated based on erroneous results.3.If yes, did the erroneous treatment have any adverse impact to the patient(s)? n/a.".

Manufacturer Narrative

H6: investigation summary customer reported a false positive defect, stainable and viable contamination.One photo was provided.Returned good samples are not available.Bd was unable to reproduce customer experience with the bactec product.A false positive response was not observed when retention samples were tested.Retention samples were visually inspected, tested for viable contamination by sub-culturing on tsa, chocolate, sabouraud and schaedler agars plates, voltage output and gram stain.All results were satisfactory.Batch history records were reviewed, and all testing were within specification for product release.A complaint history review was conducted and only the current complaint was found relating to the incident lot number and the ¿as reported¿ defect code.Complaint is unconfirmed based on retention samples and batch history record review.H3 other text : see h10.

• Brand Name: BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13081231
• MDR Text Key: 289513453
• Report Number: 2647876-2021-00368
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420239
• UDI-Public: 00382904420239
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K113558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2022
• Device Model Number: 442023
• Device Catalogue Number: 442023
• Device Lot Number: 1230635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1